Quality Assurance Specialist - Somerville, United States - Deephealth

Deephealth

Verified Company

Somerville, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Job Description:

Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, RadNet is _Leading Radiology Forward_.

With dynamic cross-training and advancement opportunities in a team-focused environment, the core of RadNet's success is its people with the commitment to a better healthcare experience.

When you join RadNet as a
Quality Assurance Specialist_,_** you will be joining a dedicated team of professionals who deliver quality, value, and access in the 21st century and align all stakeholders
- patients, providers, payors, and regulators achieve the best clinical outcomes.

JOB SUMMARY

The Quality Assurance Specialist is responsible for supporting the Quality Management System throughout the organization in support of product maintenance, development, and growth.

The Quality Assurance Specialist will, with direction, be responsible for document management, QMS training, complaint and CAPA management.

You will:

Own and lead the document management process, including configuration management.
Work crossfunctionally to lead the complaint management process, including investigations, customer interactions, and reporting to management
Lead the CAPA management process to work cross functionally to identify root causes, and implement remediations
Lead the QMS training (and retraining) to ensure compliance with US and International requirements.
Assist in the evaluation and qualification of suppliers.
Complete Quality System Audits (internal and external audits) to ensure compliance.

If You Are:

Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, coworkers, patients, visitors, and vendors.
Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
Participation in regulatory audits
Excellent written and oral communication skills

To Ensure Success In This Role, You Must Have:

Bachelor's degree in relevant field (or equivalent experience, i.e. Associates Degree with 3 years of experience)
Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62034 preferred.

years working in a regulated industry (FDA and Software as a Medical Device preferred)

Pay Range:
USD $100, USD $160,000.00 /Yr

Shift:

Flexibility Required Shift Variations:
day